Transcript 5% - chemitex

Prehistory terminology
Probiotics/Prebiotics
Food fibers
Lactulose
Enterosorbents
Lignin
Lactofiltrum
Probiotics are beneficial bacteria that can be introduced into
the digestive system with food. They enhance immunity,
help regulate hormone balance, protect from food poisoning,
allergies, and perform other important functions.
Prebiotics are non-digestible carbohydrates that pass
through the small intestine undigested and are fermented in
the colon by beneficial bacteria thus activating their growth.
Enterosorbents are substances that bind and deduce
exogenous and endogenous toxins as well as pathogenic
microorganisms and their metabolites from the
gastrointestinal tract .
Composition
Medicinal lignin fibers, mg
375,0
Lactulose, mg
125,0
Moisture, %
5, 0
Total tablet weight, mg, + 5%
500,0
Specification of components:
Medicinal lignin by Russian manufacturers standard
(approved by the Ministry of Health) FSP 42-02363083-02
Shelf life: 3 years
Lactofiltrum is patented in 1999.
Expiry date 2019
Lignin active substance and Lactofiltrum (as finished product)
are manufactured on the own plant in accordance with GMP
standards. Lignin modified preparation technology and
sterilization were elaborated on the basis of the own patent
(1999).
Lactulose (complies with Lactulose Concentrate USP26)
New generation prebiotic for
elimination of intestinal pathogenic
microorganisms and their toxins as
well as for activation of own
bifidobacteria growth, which
normalizes microflora balance  Dysbacteriosis of different etiology (gastrointestinal chronic and acute diseases, long-term
therapy by anti-inflammatory non-steroids,
immunosuppresants etc.)
Indications:

Irritated bowel syndrome with a tendency to
constipation and unstable stool

Rehabilitation of microflora disbalance after
antibiotic therapy (incl. antibiotic-associated
diarrhea)

In complex therapy of atopic dermatitis (diathesis)
particularly in pediatric practice

Combined treatment of acute and chronic viral
hepatitis and hepatic cirrhosis.

General improvement of intestinal microbiological
ecology (for aging population)
Dysbacteriosis or
microflora disbalance
Vital aspects of abnormal microflora in children
Dysbacteriosis or microflora disbalance:
 Microflora disorders are diagnosed in 90% children
 Slows down vitamins and minerals absorption thus negatively affecting development of
bone, muscle and nervous systems as well as immunity
 Often causes or aggravates atopic dermatitis
 Has negative destructive influence on the intestinal mucosa causing various gastrointestinal chronic diseases
Vital aspects of normal microflora in adults and aged people
Normal microflora
Prevents septic processes in intestines and colon
Results in decreasing internal intoxication
Improves absorption of vitamins and minerals preventing osteoporosis
Has beneficial effect on immunity and general physiological activity
Features
DOUBLE MECHANISM INFLUENCE ON
MICROFLORA
Lignin - natural
enterosorbent, adsorbs
wide range of endo- and
exogenous toxins and
pathogenic
microorganisms in the
intestines
100 %
Normalization of intestinal
microflora
Lactulose - improves
growth and activity of
lacto - and
bifidobacteria
Аdvantages vs traditional
probiotic therapy
LACTOFILTRUM®
(as prebiotic)
Direct absorption of pathogenic
microflora and its toxins
Free transit through gastro-intestinal
tract with minimum efficacy loss
Direct stimulation of own
normal microflora growth
Binds histamines and food allergens
(in allergo-dermatosis therapy)
High safety profile: can be used for a
long time without side effects
Ideal as preventive (prophylactic) means
Bacterial colonies products
(probiotics)
Unable to absorb pathogens
Substantial loss of activity in intestines due
to interference with aggressive stomach
excretion
Indirect influence on the normal microflora
growth
Unable to bind toxic organic metabolites
Restrictions for durable
usage
Prophylactic usage with cautions
Сlinical evidence
Treatment of dysbacteriosis in children,
including those with functional and chronic
gastrointestinal disturbances
Fig. 1 Improvement of clinical condition (treatment duration 14 days)
Efficacy, % patients
80
70
60
50
40
constipation
30
abdom. pain
20
meteorism
10
0
Lactofiltrum
monotherapy
Research Institute of Pediatrics (Moscow, 2003)
Standard therapy
(spasmolitics,
probiotics)
Lactofiltrum influence
on intestinal microflora
Fig. 2
Microflora composition
Normal
level
With Lactofiltrum
(n = 45)
Control (n = 15)
Before
After
Before
After
Bifidobacteria
>8
<6
>9
<7
<7
Lactobacteria
>6
<5
>8
<5
6
E.coli, weak fermentative
< 10 %
13%
5%
12%
9%
Hemolytic E.coli
0
5
0
6
2
Candida
<3
>5
0
>5
<4
Lactase-negative bacteria
<5%
7%
3%
7%
5%
Enterococcus
<7
>9
<3
>8
<3
Research Institute of Pediatrics (Moscow, 2003)
Сlinical evidence
CONCLUSIONS
DOSAGES:
 Children under 6 months - 1/4 tablet 3-4
times a day
 6 months - 1 year - 1/3 tablet 3-4 times a day
 1-3 years - 1/2 - 1 tablet 3 times a day
 4-7 years - 1 - 1,5 tablets 3 times a day
 over 7 years - 2 tablets 3-4 times a day.
1-1,5 hours before or 1-1,5 hours after meal.
Lactofiltrum treatment resulted in normalization of intestinal microflora
composition, namely, in elimination of opportunistic bacteria, suppression
of cocci and growth of Lacto- and Bifidobacteria.
CONCLUSIONS (cont.)

Lactofiltrum corrects both intestinal peristalsis and
intestinal microflora composition.
Lactofiltrum is effective in pediatric patients with
functional gastrointestinal disturbances like

Lactofiltrum can be used for conditioning therapy to
enhance the effect of further decontamination against
parasitic invasion (lambliasis)

Lacto- and Bifidobacteria-containing drugs can be
reasonably used after 14-day conditioning by
Lactofiltrum.

At least 14-day treatment by Lactofiltrum with further
analysis of feces for dysbacteriosis appears obligatory
after children are transferred from hospital to an
orphanage. This measure aims at prevention of
nosocomial infection in weak children by opportunistic
microflora.
Lactofiltrum clinical
study in patients with
dysbacteriosis
Dynamics of clinical symptoms during
Lactofiltrum treatment
120%
Appetite
Meteorism
100%
Constipation
Unstable stool
80%
60%
40%
RESULTS:
20%
Improvement of clinical
signs was associated by
alleviation of intestinal
dysbacteriosis.
0%
Before
treatment
1-st week of
treatment
State Medical University (Saratov, 2005)
2-nd week of
treatment
Atopic dermatitis accompanied
by intestinal disturbance with a
tendency to constipation and
unstable stool
Days
Treatment duration 14 days
14
Lactofiltrum + standard
therapy
12
Standard therapy (diet,
antihistamins, topicals,
enzymes)
10
8
6
Conclusions:
4
Lactofiltrum can be recommended
for monotherapy of mild atopic
dermatitis in the phase of incomplete
remission of moderate disease, and
for treatment of moderate atopic
dermatitis in combination with local
therapy.
2
0
skin hyperemia
skin pruritis
skin dryness
Scientific Center of Children Health (Moscow, 2003)
Acute viral hepatitis (A, B, C)
Lactofiltrum addition to
standard therapy of
acute viral hepatitis
results in significantly
lesser duration and
intensity of intoxication
(fatigue, headache, low
appetite, anorexia,
fever), dyspepsia, pain
and jaundice. Such
treatment is shown to accelerate
normalization of liver and thickened
gallbladder wall sizes and gallbladder
clearance of the solids compared to control
patients.
Federal Medico-Biological Agency (Moscow, 2005)
Treatment duration 21 days
Duration of the major clinical signs
Days
12
10
8
6
4
2
0
Lactofiltrum
treatment
Control group
Microflora support
during oral antibacterial
therapy
Intestinal microflora components in patients with
genitourinary chlamydiosis (lg CFU/g).
Control group: clarithromycin
Experimental group: clarithromycin
+ Lactofiltrum
8
8
7
7
6
6
5
5
4
4
3
3
2
2
1
1
0
1
2
Before treat.
After treat.
3
4
0
1
2
3
1 - Lactobacillus spp.
3 - Escherichia coli
2 - Bifidobacterium spp. 4 - Enterococcus spp.
Institute of Epidemiology and Microbiology (St.-Petersburg)
4
RESULTS
• Decrease of lactobacilli and bifidum bacteria content was
statistically significant in the control group (р<0.001 and p<
0.05 respectively).
• Analysis did not reveal significant qualitative alteration of
the studied microflora components in experimental patient
group.
CONCLUSIONS
1.
The study confirmed the efficacy of prebiotic Lactofiltrum administration for
prevention of dysbacteriosis development during chlamydiosis treatment by
macrolide antimicrobial clarithromycin.
2.
Lactofiltrum administration concomitantly with antimicrobial treatment of
chlamydiosis facilitates preservation of normal intestinal microflora and
decreases the risk of intestinal colonization by Candida spp.
3.
Lactofiltrum administration decreases the risk of antimicrobials-induced
dyspepsia and allergic reactions.
Microflora
support during parenteral
antibacterial therapy
Lactofiltrum prevention of intestinal dysbacteriosis
in surgical patients with purulent conditions receiving
prolonged antimicrobial therapy (by CEPHAZOLIN, IMIPENEM, MAXIPIME)
Study group
Control group
Dysbacteriosis parameters
Before
treatment
After
treatment
Before
treatmen
t
After
treatmen
t
Bifidobacteria (<107)
10%
5%
-
20%
Lactobacteria (<105)
5%
5%
-
30%
Lactose-negative E. coli (> 5%)
5%
-
50%
E. coli with low enzyme activity
(> 10%)
10%
-
30%
Hemolytic E. coli
5%
-
40%
Proteus spp. (>103)
10%
-
30%
Staphylococcus aureus
20%
-
40%
Military hospital №42 (St.-Petersburg)
5%
RESULTS




Potential prolonged antimicrobial therapy results in intestinal dysbacteriosis,
decrease of bifidobacteria and lacrobacteria content and appearance of
opportunistic and pathogenic microflora, including Candida spp.
Lactofiltrum administration allows prevention of intestinal dysbacteriosis
during antimicrobial therapy.
Lactofiltrum administration decreases the risk of Candidosis development
during antimicrobial therapy.
Lactofiltrum administration allows normalization of gastrointestinal tract
condition even in patients with initial dysbacteriosis – normalization of
microflora profile, stool frequency and consistence, pain, discomfort and
meteorism relief.
CONCLUSION
Lactofiltrum inclusion into combined therapy schedule significantly
alleviates both clinical and laboratory manifestations of dysbacteriosis
during prolonged parenteral antimicrobial therapy.
Sales dynamics, Russia
packs N60
1 400 000
1 200 000
1 000 000
800 000
600 000
400 000
200 000
0
2001
2002
2003
2004
2005
2006
Positioning:
key messages aspects

Double power prebiotic for improvement of
intestinal microflora in case of gastrointestinal
disorders and atopic dermatitis

High safety profile prebiotic for all groups of
population

Microflora protector during antibiotic therapy

Strengthens standard therapy efficacy in case of
microflora disorders (synergy)
R & D prospects





Product improvement for children audience: confectionery,
powders, various tastes
Miscellaneous formulations: caplets, capsules, sache, gel,
paste
Combination with additives giving synergy positive effect
for intestinal microflora
Modifying prebiotic component to reach better activation of
definite spp.
Modifying enterosorbent component to gain more specific
absorption of certain pathogens
Representação no Brasil:
R. Dr. Cândido Espinheira, 350 – 13° andar – Cj. 132
CEP 05004-000 – São Paulo/SP
Fone 55 11 3676-0546 / FAX 55 11 3676-0559
[email protected]